A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
Brief Summary

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Overall Status Completed
Start Date March 2002
Completion Date June 2005
Primary Completion Date June 2005
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary Outcome
Measure Time Frame
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths Up to Week 126
Number of Participants With Marked Laboratory Abnormalities Up to Week 126
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis From Baseline (Day -28 to Day 1) to Week 126
Mean Change in Pulse Rate Up to Week 126
Enrollment 91
Condition
Intervention

Intervention Type: Drug

Intervention Name: methoxy polyethylene glycol-epoetin beta [Mircera]

Description: Differing doses and frequencies of iv administration

Eligibility

Criteria:

Inclusion Criteria:

- adult patients >=18 years of age;

- chronic renal anemia;

- on hemodialysis therapy for at least 3 months;

- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

- women who are pregnant, breastfeeding or using unreliable birth control methods;

- use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
Facility:
| Birmingham, Alabama, 35211, United States
| Los Angeles, California, 90095, United States
| Maywood, Illinois, 60153, United States
| Louisville, Kentucky, 40202-1718, United States
| Detroit, Michigan, 48202-2689, United States
| Detroit, Michigan, 48236, United States
| Brooklyn Center, Minnesota, 55430, United States
| Las Vegas, Nevada, 89106, United States
| Paterson, New Jersey, 07503, United States
| Brooklyn, New York, 11203, United States
| Mineola, New York, 11501, United States
| New York, New York, 10128, United States
| Nashville, Tennessee, 37232, United States
| Morgantown, West Virginia, 26506, United States
Location Countries

United States

Verification Date

October 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Cohort 1 (RO0503821 [0.25/150 1x/week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Label: Cohort 2 (RO0503821 [0.25/150 1x/2week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Label: Cohort 3 (RO0503821 [0.4/150 1x/week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Label: Cohort 4 (RO0503821 [0.4/150 1x/2week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Label: Cohort 5 (RO0503821 [0.6/150 1x/week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Label: Cohort 6 (RO0503821 [0.6/150 1x/2week])

Type: Experimental

Description: Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov